The FDA based their decision on results from the Phase 3 ‘MAVORIC’ study

Kyowa Hakko Kirin announced that Breakthrough Therapy Designation status has been granted to mogamulizumab, their investigational product in clinical development for the treatment of Mycosis Fungoides (MF) and Sézary Syndrome (SS), the most common subtypes of cutaneous T-cell lymphoma (CTCL).

Mogamulizumab is a humanized monoclonal antibody (mAb) directed against CC chemokine receptor 4 (CCR4). The treatment is specifically intended for patients who have received at least one prior systemic therapy.

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The FDA’s Breakthrough Therapy designation was based on results from a Phase 3 study entitled ‘MAVORIC’. The study enrolled a total of 372 patients with MF and SS who were randomized to either receive mogamulizumab or vorinostat.

MF and SS are the two most common subtypes of CTCL, a rare type of non-Hodgkin’s lymphoma. To date, the MAVORIC study is the largest randomized trial to be conducted in CTCL.